Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
This study is a multi-center, randomized, double-blind, placebo-controlled study in
participants 1 to less than 56 years of age who are allergic to peanut and at least two other
foods (including milk, egg, wheat, cashew, hazelnut, or walnut). While each participant may
be allergic to more than two other foods, the primary endpoint/outcome in this study will
only be assessed in peanut and two other foods for each participant. The primary objective of
the study is to compare the ability to consume foods without dose-limiting symptoms during a
double-blind placebo-controlled food challenge (DBPCFC), after treatment with either
omalizumab or placebo for omalizumab.
Phase:
Phase 3
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators:
Genentech, Inc. Novartis Pharmaceuticals Rho Federal Systems Division, Inc.